The United States Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH) is pleased to announce an advanced session of the CDRH Forum for International Medical Device Regulatory Authorities scheduled for September 13-15, 2010. The CDRH Forum is established for the exchange of medical device regulatory information between the USFDA CDRH and its counterpart agencies in other countries. The training is limited to international medical device regulatory authorities.

This advanced session of the CDRH Forum for International Medical Device Regulatory Authorities is designed for experienced regulatory authorities. The course will utilize a seminar approach by presenting three case studies. All participants are expected to actively participate in addressing the various issues presented in each case.

There is no registration fee for this program. However, attendees are responsible for their own travel expenses. The program will be held at The Legacy Hotel and Meeting Center in Rockville, Maryland.

The training will be conducted in English. Translations will not be provided.

Participation in the Advanced CDRH Forum for International Medical Device Regulatory Authorities is limited to international medical device regulatory authorities. Priority seating will be given to participants who have previously attended CDRH’s Introductory Device Forum course.

Confirmation of registration and additional meeting information will be sent to approved participants.

** Registration will close August 13, 2010. Please be sure to allow enough time to obtain your visa. **

Prior to the CDRH Forum, we request participants to view the following CDRH Learning Modules using CDRHLearn:

Overview of Regulatory Requirements: Medical Devices

Quality System Regulations 21 CFR 820 Basic Introduction

Overview of Premarket Notification Process 510 (k)

If you need special accommodations due to a disability, please Lily Ng at CDRHForum@fda.hhs.gov at least 7 days in advance of the meeting.